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Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281980
Recruitment Status : Enrolling by invitation
First Posted : September 13, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty

Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour.

Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development.

Primary Hypothesis (if any):

  • Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group.
  • Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups

Secondary Hypothesis:

Additionally the intervention will

  • be cost effective,
  • reduce mothers' depressive symptoms and improve their self esteem
  • improve children's growth and household food security status
  • reduce domestic violence
  • Health seeking behaviour and health care expenditure

Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country.

Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.


Condition or disease Intervention/treatment Phase
Child Development Child Behavior Other: Psychosocial stimulation (PS) Other: Government Intervention (UCT+HE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The testers of the participants will not have the information about type of intervention of the children
Primary Purpose: Other
Official Title: Effects of Adding Psychosocial Stimulation for Children of Lactating Mothers Enroled to Receive Unconditional Cash Transfer (UCT) and Health Education Awareness Programme on Children's Cognition and Behaviour in Rural Bangladesh
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention (UCT+HE+PS)
The participants of this arm will receive UCT and HE along with psychosocial stimulation (PS)
Other: Psychosocial stimulation (PS)

i) Unconditional Cash Transfer(UCT)/ Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each mother up to two years in each month.

ii) Health Education Awareness Program: All mothers receive health education training by designated LNGOs/CBOs

iii) Psychosocial stimulation: The participants will receive fortnightly sessions at home.


Sham Comparator: Government Intervention (UCT+HE)
The participants of this arm will receive only UCT and HE
Other: Government Intervention (UCT+HE)
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No Intervention: Comparison



Primary Outcome Measures :
  1. Child development composite score [ Time Frame: Change children's cognition, language and motor as composite score after one year intervention ]
    Children's cognition, language and motor as composite score

  2. Children's behavior and composite score [ Time Frame: Change children's behaviour after one year intervention ]
    Children's behavior will be measured by Wolk's behavior rating scale during bayley


Secondary Outcome Measures :
  1. Children's weight [ Time Frame: Change children's weight after one year intervention ]
    Children's weight will be measured by Gram

  2. Children's height [ Time Frame: Change children's height after one year intervention ]
    Children's height will be measured by centimeter

  3. Children's Mid Upper Arm circumference (MUAC) [ Time Frame: Change children's MUAC after one year intervention ]
    Children's MUAC will be measured by millimeter

  4. Mothers' weight [ Time Frame: Change mother's weight after one year intervention ]
    Mothers' weight will be measured by Gram

  5. Mothers' height [ Time Frame: Change mother's height after one year intervention ]
    Mothers' height will be measured by Centimeter

  6. Mothers' depressive symptom [ Time Frame: Change mother's depression status after one year intervention ]
    Mothers' depressive symptom will be measured by Self-Regulation Questionnaire (SRQ)

  7. Mothers' level of self-esteem [ Time Frame: Change mother's level of self esteem after one year intervention ]
    Mothers' level of self-esteem will be measured by Rosenberg Self-esteem questionnaire

  8. Family's monthly food security status [ Time Frame: Change family's food security status after one year intervention ]
    Family's monthly food security status will be measured by Household Food Insecurity Access Scale (HFIAS) questionnaire

  9. Family's monthly health seeking behavior [ Time Frame: Change family's health seeking behaviour status after one year intervention ]
    Family's monthly health seeking behavior status will be measured by questionnaire

  10. Family's monthly income [ Time Frame: Change family's income status after one year intervention ]
    Family's monthly income status will be measured by questionnaire

  11. Family's monthly expenditure [ Time Frame: Change family's expenditure status after one year intervention ]
    Family's monthly expenditure status will be measured by questionnaire

  12. Domestic violence (mothers) [ Time Frame: Change family's domestic violence status after one year intervention ]
    Domestic violence (mothers) monthly status will be measured by questionnaire

  13. Family care indicators (FCI), [ Time Frame: Change of FCI after one year intervention ]
    Family care indicators (FCI) will be measured by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 16 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mothers with a child aged 6-16 months
  • Eligible to receive UCT.

    • UCT+HE+PS arm: Receiving unconditional cash from government
    • UCT+HE arm: Receiving unconditional cash from government
    • Comparison arm: eligible to receive UCT but not under UCT programme.
  • Not expected to leave the study site for more than 2 months
  • Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

  • Legal guardian unwilling or unable to provide written informed consent.
  • Known congenital anomaly
  • Developmental disorder or severe developmental delay
  • Not possible to test the child due to physical or behavioral problems
  • Children of multiple birth e.g. twin, triplets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281980


Locations
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Bangladesh
Upazilla
Sirajgonj, Bangladesh, 6761
Sirajgonj, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03281980    
Other Study ID Numbers: PR-17009
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Bangladesh
Child development
Poor mothers
Psycho social stimulation
Unconditional cash transfer